Mounted gasket for sterile cinnectors

ABSTRACT

A gasket, connector assembly and method of creating a connection is described. The gasket includes a ring portion having a thickness suitable for creating a seal when compressed between two connector fitting ends, and at least one appendage pair, where each appendage of the at least one appendage pair includes an extension for engaging a reciprocally shaped receiving component on a connector fitting end to create an at least temporarily secured attachment of the gasket to the end of the connector fitting prior to creation of a seal between two connector fitting ends. The connector assembly includes a connector fitting having at least one receiving component on an end of the connector fitting and a gasket having at least one appendage, where the at least one appendage of the gasket engages the at least one receiving component to create an at least temporary secured attachment of the gasket to the connector fitting end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority of U.S. Patent Application Ser. No.61/069,337, filed Mar. 13, 2008, and is related to concurrently filedU.S. patent application Ser. No. ______, filed Oct. 30, 2008 andentitled CONNECTOR, GASKET AND METHOD OF ATTACHING THE SAME, the entiredisclosures of which are incorporated by reference herein as if beingset forth in their entireties.

FIELD OF THE INVENTION

The instant invention relates to the field of mechanical connectors, andin particular to connectors for use in fluid processing machinery orother applications used in a sterilized environment.

BACKGROUND OF THE INVENTION

Sanitary style flange fittings have been around for decades. Forexample, steel fittings are used widely in the dairy, pharmaceutical andbiotechnology manufacturing industries.

These flange fittings typically have a hose barb (or nipple) on one sideof the fitting for securing a fluid conduit, such as a flexible hose ortube. On the other side of the fitting, a flange to make a connectionwith another fluid conduit or piece of equipment is usually found. Usingthis design, the other fluid conduit or pieces of equipment would alsoneed to have a matching flange in order to make the proper and effectiveconnection.

However, the biotech and pharmalogical manufacturing industry has beenmoving away from these steel process systems and embracing what arecommonly referred to as “single-use” systems, such as those made fromdisposable plastic parts and rubber tubing. These “single-use” systemsare extremely varied, highly customized, and built to the end-usersspecifications for a broad range of manufacturing applications.

An example of a single-use sanitary flange fitting can be found in U.S.Pat. No. 6,893,428 (“the '428 patent”), the entire disclosure of whichis incorporated by reference herein as if set forth in its entirety. Asdescribed in the '428 patent, an over-wrap bag is attached to a flangeformed near the middle of the connector. The over-wrap bag maintains thesterility of the enclosed end of the connector. The other end of theconnector is typically attached to a piece of tubing or conduit incommunication with another larger bag, which has been rendered sterilecollectively with the connector. Sterile fluids pumped into the bag,either though the connector itself, or through some other opening in thelarger bag, will not be contaminated.

In use, the flange fitting is intended to make a connection with anotherflange fitting. To make the connection, a flat rubber gasket is placedbetween the face of the fittings. The gasket is designed to seat intothe contours of the fitting face. The flange faces are pushed together(with the gasket in between) and a circular clamp is positioned aroundthe circumference of flanges. The clamp has a swing-bolt that, oncesecured in place, permits the installer to tighten the two flange facestogether and compress the gasket. Once connected, the two fittings forma fluid conduit relatively free from dead-spots and capable of handlingsubstantially high pressures.

However, a drawback to these sterile flange fittings involves theinstallation of the gasket during connection. For example, the operatormaking the connection must hold the gasket in place, while at the sametime align the flange faces and install the clamp around the fittingsand gasket. This is a clumsy, cumbersome process at best and highlyprone to contamination. Therefore, a need exists for a device, mechanismand method for readily attaching the gasket portion to the fittings of aconnector while maintaining a sterile environment.

SUMMARY OF THE INVENTION

A gasket for attachment to the face of a connector fitting is described.The gasket includes a ring portion having a thickness suitable forcreating a seal when compressed between two connector fitting ends, andat least one appendage pair, where each appendage of the at least oneappendage pair includes an extension for engaging a reciprocally shapedreceiving component on a connector fitting end to create an at leasttemporarily secured attachment of the gasket to the end of the connectorfitting prior to creation of a seal between two connector fitting ends.

A connector assembly is also described. The connector assembly includesa connector fitting having at least one receiving component on an end ofthe connector fitting and a gasket having at least one appendage, wherethe at least one appendage of the gasket engages the at least onereceiving component to create an at least temporary secured attachmentof the gasket to the connector fitting end.

A method of creating a connection between two connector fittings is alsodescribed. The method includes the steps of engaging some or all of theappendages of a gasket with a reciprocally shaped receiving component ofthe connector fitting, such that the gasket is at least temporarilysecured to the end of the connector fitting, sterilizing the gasket andconnector fitting, placing the end of a second connecter fittingadjacent to the gasket attached to the first connecter fitting, suchthat the gasket is between the ends of the two connector fittings, andclamping the two connector fitting ends and gasket such that the gasketis compressed to form a seal and thereby create a connection between thetwo connector fittings.

BRIEF DESCRIPTION OF THE FIGURES

Understanding of the present invention will be facilitated byconsideration of the following detailed description of the embodimentsof the present invention taken in conjunction with the accompanyingdrawings, in which like numerals refer to like parts and in which:

FIG. 1 is a cross sectional view of an exemplary connector, according toan aspect of the present invention;

FIG. 2A is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2B is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2C is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2D is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2E is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2F is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 2G is a front view of an exemplary connector, according to anaspect of the present invention;

FIG. 3A is a perspective view of an exemplary gasket, according to anaspect of the present invention;

FIG. 3B is a side view of the exemplary gasket of FIG. 3A, according toan aspect of the present invention;

FIG. 3C is a front view of the exemplary gasket of FIG. 3B, turned 90°;

FIG. 4A is a perspective view of an exemplary gasket, according to anaspect of the present invention;

FIG. 4B is a side view of the exemplary gasket of FIG. 4A, according toan aspect of the present invention;

FIG. 4C is a front view of the exemplary gasket of FIG. 4B, turned 90°;

FIG. 5A is a perspective view of an exemplary gasket, according to anaspect of the present invention;

FIG. 5B is a cross sectional view of an exemplary gasket and appendage,according to an aspect of the present invention;

FIG. 5C is a side view of an exemplary gasket and appendage, accordingto an aspect of the present invention;

FIG. 5D is a cross sectional view of an exemplary gasket and appendage,according to an aspect of the present invention;

FIG. 6A is a perspective view of an exemplary connector, according to anaspect of the present invention;

FIG. 6B is a perspective view of the exemplary gasket of FIG. 4Aengaging the exemplary connector of FIG. 6A, according to an aspect ofthe present invention;

FIG. 7A is a perspective view of an exemplary connector, according to anaspect of the present invention; and

FIG. 7B is a perspective view of the exemplary gasket of FIG. 5Cengaging the exemplary connector of FIG. 7A, according to an aspect ofthe present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It is to be understood that the figures and descriptions of the presentinvention have been simplified to illustrate elements that are relevantfor a clear understanding of the present invention, while eliminating,for the purpose of clarity, many other elements found in typicalmechanical connectors. Those of ordinary skill in the art will recognizethat other elements and/or steps are desirable and/or required inimplementing the present invention. However, because such elements andsteps are well known in the art, and because they do not facilitate abetter understanding of the present invention, a discussion of suchelements and steps is not provided herein. The disclosure herein isdirected to all such variations and modifications to such elements andmethods known to those skilled in the art. Furthermore, the embodimentsidentified and illustrated herein are for exemplary purposes only, andare not meant to be exclusive or limited in their description of thepresent invention.

The present invention may generally be described as including apre-mounted gasket on the face or fitting of a connector. The presentinvention provides for an improved and greatly simplified gasketinstallation process with a significantly reduced chance ofcontamination when used in a sterilized environment. This constructionand attachment mechanism eliminates the operator of the device fromhaving to locate a clean gasket in their facility. The gaskets may besterilized separately or along with the fitting and entire connectorsystem, which may remove the need for physically handling andpositioning the gasket for proper sealing and compression.

According to an aspect of the present invention and as illustrated inFIG. 1, a connector is shown having a hollow barrel 1 and connector endsformed at opposite ends of barrel 1. A flange 7 is attached to and maybe formed integrally with barrel 1 at a location on barrel 1 which isintermediate to the ends. A connector end 2, which may optionally have alarger diameter, is formed on an end of barrel 1 opposite connector end3. As shown in FIGS. 2A-2G, this general connector configuration maytake on many different embodiments, as the various types of tubing,other connectors, or other machinery to which the present invention mayconnect to can vary.

According to an aspect of the present invention, the gaskets asdescribed and illustrated herein throughout may be made of plastics,polymers, rubber, silicone, EPDM, steel, or any other material orcombination of materials that may be manufactured sterile orsubsequently sterilized by sterilization methods as understood by thoseskilled in the art.

According to an aspect of the present invention, the gasket may includeone or more appendages located on the circumference or outer edge of thegasket. These appendages may be designed for engaging the face of theconnector fitting for attachment. The appendages may be positioned atany point on the circumference of the gasket, provided that suchpositioning sufficiently provides for adequate attachment of the gasketto the face of the connector fitting. For example, the appendages andcorresponding reciprocal cavities may be alternatively positioned on theinner circumference, the outer circumference, and anywhere in between.

As shown in FIGS. 3A-3C, two appendages 310 of gasket 300 may be used,where each appendage is on the opposite side of the circumference, orapproximately 180° from each other around the circumference of theconnector fitting face. As shown in FIGS. 4A-4C, four appendages may beused, where each appendage is on an opposite side of another appendage,where each appendage is approximately 90° from each other around thecircumference of the connector fitting face. In yet another example,three appendages may be used, where each appendage is equidistant fromeach other, or approximately 120° from each other around thecircumference of the connector fitting face.

As explained previously, the gasket appendages may be designed forengaging the face of the connector fitting for attachment. Theappendages may include any shape or structure that promotes theattachment of the gasket to the connector fitting. By non-limitingexample only and referring again to FIGS. 4A-4C, the appendages areshaped as matching pairs, in that appendages 410 of gasket 400 have afirst length, such as of approximately 0.3 inches, for example, whileappendages 420 may have a second length, such as of approximately 0.484inches, for example. Likewise, a cavity or whole 430 may be specificallysized and shaped for receiving a corresponding protrusion from theconnector fitting to which the gasket must be attached.

In another embodiment of the present invention, as shown in FIGS. 5A and5B, appendage 510 of gasket 500 may include an overhanging portion 520for engaging a groove or other reciprocal portion of the connectorfitting. In yet other embodiments, such as that shown in FIG. 5C, forexample, appendage 510 of gasket 500 may include a “T” shaped block 530for engaging the connector fitting. The gasket appendages mayalternatively be substantially u-shaped, v-shaped, a loop shape or anyother shape suitable for engaging and interlocking with the cavities orreciprocal spaces positioned in the face of the connector fitting priorto compression. Further still, as shown in FIG. 5D, appendage 510 ofgasket 500 may include a barbed portion 540 for engaging a reciprocalportion of the connector fitting. The gasket may also include one ormore additional connecting mechanisms, such as a detent between thegasket and the connector fitting.

It should be appreciated that any shape or combination of shapes of oneor more of the appendages may be used, provided the construction usedpromotes a reliable attachment of the gasket to the face of theconnector fitting. In all cases, the gasket attachment may be temporary,meaning the gasket may be removed from the connector fitting, or it mayalternatively be substantially permanent, meaning the gasket cannot beremoved the connector fitting without at least a partial destruction ofthe gasket and/or connector fitting.

Likewise, the face of the connector fitting may have one or morecavities or reciprocal spaces sized and shaped for receiving and/orinterlocking with the appendages of the gasket described herein. Anysort of protrusion, such as a shelf or hanger portion may be of anyshape or contour, and may extend from within the cavity or from theouter edge of the circumference of the connector fitting face, providedsuch extension does not ultimately interfere with a clamp for connectingthe two connector ends and gasket to create a seal suitable for a fluidconnection. These cavities or reciprocal spaces, including anyprotrusions, may serve as “key slots” for engaging, receiving and/orinterlocking the corresponding gasket appendages, and therefore creatinga “lock and key” mechanism for either a temporary or substantiallypermanent attachment of the gasket to the fitting face.

For example, as shown in FIG. 6A, connector fitting 600 may include afirst pair of matching cavities 610, inside of which is a protrusion620. Connector fitting 600 may also include a second pair of matchingcavities 630 that are larger than cavities 610, such that cavities 630reduce the radial distance of the outer edge of the connector fittingcircumference. Likewise, cavities 630 may include their own protrusion640. As shown in FIG. 6B, gasket 650 may engage connector fitting 600for a temporary but secure attachment. As shown, the first gasketappendage pair 660 having a hole therein engages reciprocal connectorfitting cavities 610, with protrusion 620 fitting within the hole ofappendage 660. Likewise, the second gasket appendage pair 670, alsohaving a hole therein, engages reciprocal connector fitting cavities630, with corresponding protrusion 640 fitting within the hole ofappendage 670. In another embodiment as shown in FIGS. 7A and 7B,connector fitting 700 may include matching “T” shaped cavities 710, forreceiving corresponding “T” shaped appendages 730 of gasket 720. Itshould be appreciated that this connection mechanism may work for anygasket appendage and reciprocal cavity shapes as described herein and asunderstood by those skilled in the art.

The number of such cavities or reciprocal spaces should at least beequal to the number of gasket appendages. Additional cavities orreciprocal spaces may be present, provided such spaces do not interferewith the sealing of the fittings and gasket structure when compressed.

During manufacture of the fitting, the gasket appendages may beinstalled to the connector fitting face prior to sterilization and/orsealing of any surrounding pouch. Adhesives and/or various thermalmethods, as understood by those skilled in the art, may also be used inconjunction with the attachment mechanism as described herein.

The present invention also includes a method of creating a connectionbetween two connector fittings. For example, in no particular order, themethod may include the steps of engaging some or all of the appendagesof a gasket with a reciprocally shaped receiving component of theconnector fitting, such that the gasket is at least temporarily securedto the end of the connector fitting, sterilizing the gasket andconnector fitting, placing the end of a second connecter fittingadjacent to the gasket attached to the first connecter fitting, suchthat the gasket is between the ends of the two connector fittings, andclamping the two connector fitting ends and gasket such that the gasketis compressed to form a seal and thereby create a connection between thetwo connector fittings. The method may alternatively require that thegasket and first connector fitting are sterilized prior to securing thegasket to the first connector fitting, or may alternatively require thatthe gasket and first connector fitting are sterilized subsequent tosecuring the gasket to the first connector fitting.

Those of ordinary skill in the art will recognize that manymodifications and variations of the present invention may be implementedwithout departing from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modification andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

1-11. (canceled)
 12. A gasket for attachment to the face of a connectorfitting, comprising: a ring portion suitable for creating a seal whencompressed between two connector fitting ends; and at least oneappendage pair, wherein each appendage of the at least one appendagepair includes an extension for engaging a reciprocally shaped receivingcomponent on a connector fitting end to at least temporarily secureattachment of the gasket to the end of the connector fitting prior tocreation of a seal between two connector fitting ends.
 13. The gasket ofclaim 12, wherein the gasket is sterile.
 14. The gasket of claim 12,wherein each appendage of the at least one appendage pair includes ahole sized to receive a protrusion extending from a cavity within saidreciprocally shaped receiving component of said a connector fitting whensaid gasket is attached to said connector fitting end.
 15. The gasket ofclaim 12, wherein each pair of the at least one appendage pairs are ofdifferent sizes that correspond to at least an equal number ofreciprocally shaped receiving components.
 16. The gasket of claim 12,wherein at least one of the at least one appendage pair includes anoverhanging portion.
 17. The gasket of claim 12, wherein at least one ofthe at least one appendage pair is “T”-shaped.
 18. The gasket of claim12, wherein at least one of the at least one appendage pair includes abarbed portion.
 19. The gasket of claim 12, wherein at least the ringportion of said gasket is composed of silicone.
 20. The gasket of claim12, wherein the ring portion includes at least one ridge for engaging areciprocal groove in the face of the connector fitting end to which thegasket attaches.